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. 2022 Dec 6;2022(12):CD013601. doi: 10.1002/14651858.CD013601.pub2

Yano 2021.

Study characteristics
Methods Study characteristics
  • Study design: parallel RCT

  • Study duration: November 2015 to June 2016

  • Study follow‐up: 3 months

Participants Baseline characteristics
  • Country: Japan

  • Setting: university hospital (1 site)

  • Inclusion criteria: stable HD patients; > 20 years; ESKD undergoing HD; carnitine deficiency, defined as having both free carnitine levels < 36 μmoL/L, and acylcarnitine free/carnitine ratio < 0.4

  • Randomised number (intervention group/control): 10/10

  • Dialysis modality: HD

  • Mean age ± SD (years): intervention group (57.1 ± 11.1); control group (53.9 ± 16.5)

  • Sex (M/F): intervention group (6/4); control group (6/4)

  • Dialysis duration: not reported

  • Exclusion criteria: contraindications for L‐carnitine; pregnant women, or those possibly pregnant; patients deemed inadequate by a physician; or those suffering from symptomatic CVD or musculoskeletal disorders interfering with exercise training

Interventions Intervention group
  • L‐carnitine (IV): 1000 mg at each dialysis session for 3 months


Control group
  • Cycle ergometer exercise during HD sessions

Outcomes Outcomes relevant to this review
  • Muscle weakness: 10‐minute walk test, chair‐stand test

  • Anaemia‐related markers: Hb

Notes Funding source: a Grant‐in‐Aid for Welfare and Scientific Research from the Ministry of Education, Culture, Sports, Science, and Technology of Japan. One of the authors has received honoraria, including lecture fees, from Otsuka Pharmaceutical Co., Ltd
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "randomly assigned using simple randomization procedures (computer‐generated list of random numbers) "
Allocation concealment (selection bias) Low risk Quote: "the allocation was concealed by finishing the randomization"
Blinding of participants and personnel (performance bias) High risk Quote: "open‐label" study
Blinding of outcome assessment (detection bias)
Muscle symptoms High risk Quote: "open‐label" study
Blinding of outcome assessment (detection bias)
Anaemia‐related markers Low risk The outcome measurement is not likely to be influenced by lack of blinding
Incomplete outcome data (attrition bias)
Muscle symptoms Low risk All patient outcome data reported
Incomplete outcome data (attrition bias)
Anaemia‐related markers Low risk All patient outcome data reported
Selective reporting (reporting bias) Low risk Pre‐specified outcomes of interest to this review were reported
Other bias High risk Funding source: a Grant‐in‐Aid for Welfare and Scientific Research from the Ministry of Education, Culture, Sports, Science, and Technology of Japan. One of the authors has received honoraria, including lecture fees, from Otsuka Pharmaceutical Co., Ltd